HomeKorea, RepublicARUM DENTISTRY Co., Ltd.

ARUM DENTISTRY Co., Ltd.

Korea, Republic · Yuseong-Gu Daejeon
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Saudi Arabia, Taiwan, Singapore, Australia — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
7listed device types
Class I 2Class II 5Class III 0
plus 20 registration records and 17 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
5registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
5valid device licences
Class I 5
SGSingaporeHSA SMDR
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
9active ARTG entries
Class I 5IIb 4
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States20 registration records, 17 510(k), 0 PMA
Saudi Arabia5 confirmed, 0 excluded
Manufacturer names merged into this page: ARUM DENTISTRY Co., Ltd.

Company information

Country
Korea, Republic
City
Yuseong-Gu Daejeon

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12020
12021
22022
42023
52024 · K242245
42025 · K250280

FDA listed device types

Abutment, Implant, Dental, Endosseous 1Material, Tooth Shade, Resin 1Powder, Porcelain 1Crown And Bridge, Temporary, Resin 1Implant, Endosseous, Root-Form 1Drill, Dental, Intraoral 1Accessories, Implant, Dental, Endosseous 1

Registration details (sample)

MarketIdentifierNameClass / date
USK250280SD TL Implant System2025-07-23
USK250063ARENA Star, Galaxy Star2025-07-10
USK241703SD Implant System2025-02-24
SAME0000007507SFDAA00001Arum Screw Driver
SAME0000007503SFDAA00001Lab Analog

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